Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Completed

Conditions: Pulmonary Fibrosis

Interventions: Drug: BIBF 1120

Registration Number: NCT01170065

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.

The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).

As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 198

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIBF 1120 medium bid	BIBF 1120	Intermediate dose BIBF 1120 twice daily
BIBF 1120 low qd	BIBF 1120	Low dose BIBF 1120 once daily
BIBF 1120 low bid	BIBF 1120	Low dose BIBF 1120 twice daily
BIBF 1120 high bid	BIBF 1120	High dose BIBF 1120 twice daily

Primary Outcome Measures

Name	Time	Method
Annual Rate of Decline in Forced Vital Capacity (FVC)	From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months	Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months	Overall survival is defined as the time from the first intake of nintedanib in trial 1199.35 to death. For presentation of overall survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment survival is calculated within each treatment arm.
Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation	From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months	Percentage of patients with at least one acute idiopathic pulmonary fibrosis (IPF) exacerbation are presented. An exacerbation was defined as otherwise unexplained clinical features occurring within 1 month including all of the following: * Progression of dyspnoea over several days to 4 weeks * New diffuse pulmonary infiltrates on chest X-ray and/or high-resolution computerised tomography (HRCT) Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit * A decrease in arterial oxygen partial pressure (PaO2) of ≥10 mmHg or PaO2/fraction of inspired oxygen (FiO2) of \<225 mmHg since the last visit * Exclusion of infection based on routine clinical practice and microbiological studies * Absence of other contributory causes such as congestive heart failure, pulmonary embolism, etc.
Progression-Free Survival	From first trial drug intake in 1199.35 to disease progression; up to 61.8 months	Progression-free survival was defined as the time from the first nintedanib intake in trial 1199.35 to disease progression. For presentation of progression-free survival results, Kaplan-Meier estimates and confidence intervals (using Greenwood variance formula) for the overall on-treatment progression-free survival is calculated within each treatment arm.
Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease	From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months	Haemoglobin corrected DLCO decrease was a secondary endpoint for the trial. It was considered important that all investigators used the same method of testing and recording data at each visit for each patient. Haemoglobin corrected DLCO was calculated for each patient using the following formulae: Males: Hb corrected DLCO = measured DLCO x (10.22 + Hb concentration) / (1.7 x Hb concentration) Females: Hb corrected DLCO = measured DLCO x (9.38 + Hb concentration) / (1.7 x Hb concentration). Annual rate of decline in haemoglobin corrected diffusing capacity of the lung for carbon monoxide (DLCO) decrease is presented.
Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs	From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days	Percentage of patients with at least one Adverse events (AEs), with investigator defined drug-related AEs, AEs leading to discontinuation of trial drug, serious AEs are presented
Incidence of Patients With at Least One Acute IPF Exacerbation Over Time	From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months	Incidence rate = (Patients with at least one acute IPF exacerbation / Total number of years at risk) x 100
Time to First Acute IPF Exacerbation	From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months	Due to rare events, the median of time to event is not calculable, thus Kaplan-Meier estimates (providing the percentage of patients without acute IPF exacerbation for a certain amount of time after treatment) and confidence intervals (using Greenwood variance formula) are reported and presented within each treatment arm as secondary endpoint.

Trial Locations

Locations (57): INSARES
🇦🇷
Mendoza, Argentina
Respiratory Clinical Trial Pty Ltd.
🇦🇺
Glen Osmond, South Australia, Australia
The Queen Elizabeth Hospital
🇦🇺
Woodville, South Australia, Australia
Royal Perth Hospital-Lung Transplant Unit
🇦🇺
Perth, Western Australia, Australia
ULB Hopital Erasme
🇧🇪
Bruxelles, Belgium
UZ Leuven
🇧🇪
Leuven, Belgium
Yvoir - UNIV UCL de Mont-Godinne
🇧🇪
Yvoir, Belgium
Irmandade Santa Casa de Misericordia de Porto Alegre
🇧🇷
Porto Alegre, Brazil
Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic
🇧🇬
Sofia, Bulgaria
QEII Health Sciences Centre (Dalhousie University)
🇨🇦
Halifax, Nova Scotia, Canada
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INSARES
🇦🇷Mendoza, Argentina